The present invention relates to the incorporation of long chain alcohol substances, more specifically the present invention relates to the encapsulation of long chain alcohols so as to more readily incorporate them into foods.
Long chain alcohols, including policosanol, are therapeutically useful materials with efficacy in lowering cholesterol or blood lipids, inhibiting platelet aggregation and improving stamina. Therefore, the incorporation of long chain alcohols such as policosanol in various foods is desirable.
Incorporation of policosanol into high fat or fat-continuous emulsion systems such margarine and margarine spreads is complicated by the functional properties of policosanol. In particular, incorporation of policosanol into a margarine oil system containing a diglyceride and a phospholipid causes an increase in the hardness of a margarine type product as disclosed in WO 98/47385. In addition, EP 0991804 discloses that the incorporation of a natural long chain alcohol in a fat continuous system reduces the viscosity and yield values of confectionery products.
Despite these disclosures there is still an ongoing need to be able to add long chain alcohols to foods in a manner that the long chain alcohol will be easily formulated, will remain stable during storage, and will not adversely affect the properties of the food.
The present invention provides comestibles containing a long chain alcohol in an amount sufficient to reduce cholesterol in a vertebrae, said long chain alcohol encapsulated in a food grade acceptable material selected from a polymer, waxes and plasticizers. The present invention also provides methods for providing these comestibles. The present invention also provides methods for lowering cholesterol in a vertebrate by administering these long chain alcohols in comestible form.
The present invention is directed to the encapsulation of long chain alcohols and the incorporation of these alcohols into food products. By long chain alcohols, it is understood to mean both saturated and unsaturated alcohols of C20 and above, primarily from C20 to C36. As used herein, long chain alcohols are understood to be those materials which contain more than about 90 weight percent C20 or longer, primarily aliphatic alcohol materials. For the greatest health benefit it is preferred that the long chain alcohols be greater than 50 percent, octacosanol (C28 ), preferably more than 65 percent, more preferably greater than about 70 weight percent octacosanol. As used herein policosanol is understood to be a mixture of long chain alcohols ranging from C20 to C36 with greater than 50 weight percent C28, preferably greater than 65 weight percent C28. Common distribution and concentration ranges of the various components of policosanol are disclosed in U.S. Pat. No. 5,856,316, hereby incorporated by reference as if set forth in its entirety. The most preferred source of long chain alcohols is waxes, particularly sugar cane wax. The long chain alcohols can also be synthesized using techniques known in the art.
The level of long chain alcohol in the food product is determined by serving size. It is desirable to provide in a single serving an effective amount of the long chain alcohol to derive the desired physiological benefits, such as reduced platelet aggregation, reduced lipid and cholesterol levels and the like. Typically the level of the long chain alcohol is from about 0.1 to about 100 milligrams/serving; preferably from about 0.5 to about 20 milligrams/serving and most preferably from about 2 to about 10 milligrams/ serving.
Encapsulation as used herein is understood to mean a protective barrier to limit, if not prevent, the dissolution or dispersion into the liquid phase into which it is incorporated. The present invention contemplates surrounding the long chain alcohol by a coating of polymer. Other embodiments include multiple particles of the long chain alcohol in a matrix form surrounded by a coating. Other embodiments are possible without departing from the scope of the present invention.
There are many foods into which the encapsulated long chain alcohols are incorporated, including but not limited to aqueous based comestibles, margarine, spreads, salad dressings, cookies, confectionery products, creams, cheeses, oils, gums, candy and the like.
Numerous technologies practiced in the food and pharmaceutical industries are suitable for coating the long chain alcohol, and in a preferred embodiment for coating policosanol. These technologies are also suitable for coating long chain alcohols of C20 to C36, as well as various blends of the alcohols. The particular coatings used are intended to prevent the dissolution or dispersion of the long chain alcohol into the food or beverage product into which it is incorporated. This prevents the aforementioned physical effects of the long chain alcohol on the food or beverage product. Additionally, the coatings are intended to dissolve or disintegrate at some point in the gastrointestinal tract so that the long chain alcohol can provide physiological benefits.
Preferred methods for forming the encapsulated long chain alcohol particles are found in U.S. Pat. Nos. 5,271,881 and 5,460,756, both patents herein incorporated by reference. These patents disclose the use of a coacervation device which provides a pressure drop across an opening resulting in a coating or the mixing of coatings which would encapsulate the long chain alcohol. These patents also disclose a method for entrapping liquids in a lipid matrix by melting the lipid, adding the liquid to the melted wax, placing the admixture where it may be subjected to the action of a piston, subjecting the liquid/lipid to at least one stroke of the piston and allowing the lipid to solidify.
In an alternative process, a coating, preferably a combination of hydroxypropylmethylcellulose/polyethylene glycol are supplied in a defined ratio, preferably in a 9:1 weight ratio dissolved in an ethanol/water mixture. The coating is applied onto long chain alcohol, such as policosanol (Garuda International, Santa Cruz, Calif.) using air fluidized bed techniques employed in the pharmaceutical arts.
It is preferred that the long chain alcohols of the present invention are of a particle size less than about 35 microns, preferably from about 10 to about 30 microns and most preferably from about 15 to about 25 microns. Particle size reduction of the long chain alcohol is carried out through techniques that are known in the art, including but not limited to grindings, hammermills, cryogenic grinding, spray congealing, and the like. Particles in this size range minimize any aesthetic problems of coarseness or grittiness in the product, but are sufficiently large so that the mass of coating applied does not constitute a disproportionately large portion of the particle.
The encapsulating coating materials of the present invention are selected from the group consisting of food grade acceptable materials including waxes, natural polymers, cellulosic materials, synthetic polymers and synthetic elastomers. Waxes include glycerin tristearate, distearate, canola wax, soya flakes, rapeseed wax, glyceryl cotton flakes, castor wax, beeswax, carnauba wax, candelella wax and the like.
Suitable polymers include naturally derived celluose derivatives such as cellulose acetate, cellulose acetate butyrate, cellulose acetate phthalate, hydroxypropylcellulose, hydroxypropylmethylcellulose, methylcellulose, cellulose triacetate and ethylcellulose. Other synthetic polymers include polyvinylpyrrolidone, methylaminoethylmethacrylate and neutral methacrylic acid esters, 2-vinyl pyrridine styrene copolymer, polyoxyethylene, and polyoxypropylene. Other natural polymers include arabinogalactan, alginate, zein, xanthan gum, gum arabic, gelatin, and tragacanth gum. Mixtures of the above-described coating materials are also contemplated by the present invention.
The weight ratios of the long chain alcohol to food grade acceptable material can vary broadly from about 1:4 to about 10:1. Preferably the weight ratio of the long chain alcohol to the encapsulating material is greater than 60:40; more preferably greater than about 70:30 and in a highly preferred embodiment greater than about 80:20. The encapsulating material can be a single material or a mixture of coatings. In a highly preferred embodiment multiple coatings can be sequentially applied to the long chain alcohol. For example, an elastomeric coating can be the outermost coating to protect an inner coating which could be a blend of hydrophilic and hydrophobic materials. The blending of the encapsulating material would be dependent on the food to which the long chain alcohol is incorporated. highly preferred embodiment multiple coatings can be sequentially applied to the long chain alcohol. For example, an elastomeric coating can be the outermost coating to protect an inner coating which could be a blend of hydrophilic and hydrophobic materials. The blending of the encapsulating material would be dependent on the food to which the long chain alcohol is incorporated.
Varying the encapsulating materials allows the long chain alcohol to be more readily suspended in hydrophilic or hydrophobic systems. In another embodiment of the invention, both hydrophilic and hydrophobic encapsulating materials can be applied to the long chain alcohol. This will provide a long chain alcohol that is found throughout the food products that contain both lipid and aqueous regions such as margarine. Other coating materials can be applied such as an enteric coating such as cellulose acetate phthalate, polyvinylacetate phthalate, hydroxypropyl methylcellulose phthalate, and EUDRAGIT L-30-D (anionic polymers based on methacrylic acid and methacrylic acid esters commercially available from Rohm Pharma GmbH, Germany) and the like; as well as reverse enteric coatings such as EUDRAGIT E-100 (methylaminoethyl-methacrylate and neutral methacrylic acid esters available from Rohm Pharma GmbH, Germany) and the like.
In a preferred embodiment, policosanol is coated with a lipophilic material such as polyvinylpyrridonne and is dispersed and suspended in the oil phase while policosanol coated with a hydrophilic material such as hydroxypropylmethylcellulose is dispersed and suspended in the aqueous phase in a margarine product.
In a highly preferred embodiment, ingredients which have desirable physiological actions are also added to the food. Such materials include soy, vitamins, minerals and the like. In a highly preferred embodiment, a second cholesterol-lowering ingredient, such as oryzanols, stanols, sterols, stanol esters and sterol esters, is provided in an effective amount in the food. A particularly preferred sterol ester is xcex2-sitosterol. These materials are well known in the art and are disclosed in U.S. Pat. Nos. 3,881,005; 5,502,045; 5,869,708 and 5,892,068. The level of sterol or stanol used in the present invention should be sufficient to provide an amount effective to lower cholesterol in a human when consumed on a routine basis. Typically the sterol level is from about 0.1 to about 20, preferably from about 0.3 to 10, and most preferably from about 0.5 to about 4 grams per serving.
If the stanols/sterols are present, these materials preferably should be melted and blended with the coated particles of long chain alcohols and in a preferred embodiment with suitable ingredients before the long chain alcohol material is dispersed in the oil phase. Suitable oil sources include sunflower, safflower, corn, soybean, canola mixtures of these oils and the like.
While particle size of the long chain alcohol can vary widely, a preferred embodiment is to have the long chain alcohol to be less than about 200 microns in diameter. A highly preferred embodiment is to produce stable microencapsulated policosanol or coated microparticles of the long chain alcohol, preferably policosanol, having a diameter of less than 30 microns, preferably from about 15 to about 25 microns in diameter, that are dispersible in lipid or aqueous emulsion systems of foods.
It is the intention of the invention to produce coated policosanol particles that would not dissolve when dispersed in an oil phase or aqueous phase. Since the encapsulated policosanol is not dissolved in the oil phase, it is prevented from inducing any changes in the consistency or physical qualities of a finished product. The sizes of the particles within the coated policosanol material were limited to less than 30 microns to induce a creamy mouthfeel.
The encapsulated long chain alcohols can be advantageously incorporated into various food, beverage and pharmaceutical forms. Among those products include salad dressings, margarines, mayonnaise dressings, nutrition bars, beverages, juices, ice cream, yogurts, frozen yogurts, non-dairy creamers, cheese spreads, cheeses, milk products, confectioneries, chocolate-containing products such as cakes and cookies. Other forms include pharmaceutical preparations such as tablets, soft gelatin capsules, suspensions, emulsions and the like. The encapsulated long chain alcohols of the present invention are advantageously used to lower the cholesterol level of vertebrates, including mammals, amphibians, reptiles and the like. Most preferably the long chain alcohol is administered to a human to lower the cholesterol level of a human.